Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that INCIVEK™ (telaprevir) tablets are now available in Canada for people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver, but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK (in-SEE-veck) was approved by Health Canada in August 2011 for use in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C, and is indicated for people who are new to treatment, and for all three major groups of people (relapsers, partial responders and null responders) who were treated previously but who did not achieve a sustained viral response (SVR, or viral cure).
“INCIVEK represents an important turning point in the treatment of hepatitis C, and we are pleased to bring this new medicine to people in Canada”
INCIVEK will be the first medicine marketed by Vertex in Canada. Vertex has established its Canadian headquarters in Laval, Quebec where the company currently employs approximately 40 scientists focused on drug discovery and development activities. The company is also building medical and commercial teams to support the use of INCIVEK in Canada, and with the launch of INCIVEK, Vertex plans to continue the expansion of its Canadian workforce, both in Laval and in field-based positions throughout Canada.
"INCIVEK represents an important turning point in the treatment of hepatitis C, and we are pleased to bring this new medicine to people in Canada," said Amit K. Sachdev, Senior Vice President and General Manager for Vertex Pharmaceuticals (Canada) Incorporated. "Today marks a significant step in our commitment to improving the treatment of hepatitis C in Canada, and we are working diligently to ensure people who need this medicine are able to get treatment as quickly as possible."
The Canadian approval of INCIVEK was based on data from a global Phase 3 clinical trial program that enrolled more than 2,500 people with hepatitis C, including patients in Canada. In these studies, people who received INCIVEK combination treatment achieved significantly higher rates of viral cure compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience. With INCIVEK combination therapy, more than 60 percent of people new to treatment and those who relapsed after previous therapy are expected to be eligible to complete all treatment in 24 weeks. All other patients receive a total of 48 weeks of treatment. Phase 3 trials showed the following rates of viral cure with INCIVEK combination treatment compared to pegylated-interferon and ribavirin alone:
In addition, people who had severe liver disease also achieved significantly higher rates of viral cure with INCIVEK combination treatment compared to treatment with pegylated-interferon and ribavirin alone: 62 percent versus 33 percent for those new to treatment with advanced fibrosis or cirrhosis (F3/F4 Metavir) and 87 percent versus 13 percent for people with cirrhosis (F4 Metavir) who relapsed after prior therapy. The Canadian Product Monograph also includes Phase 3 clinical data that showed 68 percent of people new to treatment achieved a rapid virologic response (RVR; had no detectable virus after 4 weeks of treatment) with INCIVEK combination therapy, versus 9 percent for those who received pegylated-interferon and ribavirin alone. RVR is a strong predictor of a person's likelihood of achieving a viral cure.
Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.
"The Canadian availability of INCIVEK is an important milestone in the fight against hepatitis C, with many people now expected to be able to complete treatment in half the time previously needed with pegylated-interferon and ribavirin alone," said Robert Myers, MD, Associate Professor and Director of the Viral Hepatitis Clinic at the University of Calgary and an INCIVEK investigator. "This is an encouraging advancement for people with hepatitis C, and we hope that Canadians who need treatment will have access to this important new medication."
Vertex has initiated the process to make INCIVEK accessible to people in Canada through private health insurers and through the provincial and federal drug plans in Canada. The company will implement a comprehensive patient support program to provide financial assistance for costs associated with INCIVEK for people who meet certain program criteria and to provide other support services related to treatment with INCIVEK. Additionally, patients will have access to nurses through a 24-7 hotline where they can receive support, guidance and educational materials about hepatitis C and its treatment. Vertex will also provide nurses and doctors with educational tools and resources so they can offer support and care to their patients with hepatitis C before, during and after the treatment process.
Vertex Pharmaceuticals Incorporated